NICABATE MINI LOZENGES nicotine 2 mg (as polacrilex) mint flavour lozenge tube

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

nicotine polacrilex, Quantity: 10 mg (Equivalent: nicotine, Qty 2 mg)

Tersedia dari:

Haleon Australia Pty Ltd

Bentuk farmasi:

Lozenge

Komposisi:

Excipient Ingredients: indigo carmine aluminium lake; sucralose; sodium bicarbonate; mannitol; magnesium stearate; hypromellose; acesulfame potassium; xanthan gum; sodium carbonate; microcrystalline cellulose; crospovidone; xylitol; calcium hydrogen phosphate; Flavour

Rute administrasi :

Buccal

Unit dalam paket:

60, 20, 120

Jenis Resep:

Not scheduled. Not considered by committee, Not Scheduled after consideration by Committee

Indikasi Terapi:

For the relief of nicotine withdrawal symptoms including cravings associated with smoking cessation. It may also be used as part of a smoking reduction strategy by smokers who are unable or not ready to stop smoking abruptly as a step towards stopping smoking. It should be used as part of a behavioural support programme.

Ringkasan produk:

Visual Identification: A dual layer oval lozenge with convex surfaces. One side is white to off white, may contain bluish hue and the other side blue with a debossed ?2? logo; Container Type: Tube; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status otorisasi:

Registered

Tanggal Otorisasi:

2022-07-11

Karakteristik produk

1
AUSTRALIAN PRODUCT INFORMATION
NICABATE MINI LOZENGES (NICOTINE) MINT FLAVOUR
1
NAME OF THE MEDICINE
Nicotine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
_Nicotine polacrilex _
Nicotine 2 mg lozenge
Nicotine 4 mg lozenge
_Excipients: _For the full list of excipients, see section 6.1 List of
Excipients._ _
3
PHARMACEUTICAL FORM
NICABATE MINI LOZENGES NICOTINE 2 MG MINT FLAVOUR
A dual layer oval lozenge with convex surfaces. One side is white to
off white, may contain
bluish hue and the other side blue with a debossed “2” logo.
NICABATE MINI LOZENGES NICOTINE 4 MG MINT FLAVOUR
A dual layer oval lozenge with convex surfaces. One side is white to
off white, may contain
bluish hue and the other side blue with a debossed “4” logo.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the relief of nicotine withdrawal symptoms including cravings
associated with smoking
cessation. It may also be used as part of a smoking reduction strategy
by smokers who are
unable or not ready to stop smoking abruptly as a step towards
stopping smoking. It should
be used as part of a behavioural support programme.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DIRECTIONS FOR USE
One lozenge should be placed in the mouth and allowed to dissolve.
Periodically, the lozenge
should be moved from one side of the mouth to the other and repeated,
until the lozenge is
completely dissolved (approximately 10 – 13 minutes). The lozenge
should not be chewed or
swallowed whole.
2
Users should not eat or drink while a lozenge is in the mouth.
ADULTS (18 YEARS AND OVER INCLUDING THE ELDERLY)
ABRUPT CESSATION OF SMOKING
Nicabate Mini Lozenges 2 mg are suitable for smokers who smoke less
than 20 cigarettes a
day.
Nicabate Mini Lozenges 4 mg are suitable for smokers who smoke 20 or
more cigarettes a
day.
Users should make every effort to stop smoking completely during
treatment with Nicabate
Mini Lozenges.
Behavioural therapy, advice and support will normally improve the
success rate.
Users should follow the schedule of treatmen